WO2016035741A1 - Cathéter et procédé de fabrication de celui-ci - Google Patents

Cathéter et procédé de fabrication de celui-ci Download PDF

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Publication number
WO2016035741A1
WO2016035741A1 PCT/JP2015/074625 JP2015074625W WO2016035741A1 WO 2016035741 A1 WO2016035741 A1 WO 2016035741A1 JP 2015074625 W JP2015074625 W JP 2015074625W WO 2016035741 A1 WO2016035741 A1 WO 2016035741A1
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WO
WIPO (PCT)
Prior art keywords
catheter
balloon
reinforcing member
linear member
manufacturing
Prior art date
Application number
PCT/JP2015/074625
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English (en)
Japanese (ja)
Inventor
前田直之
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2016546632A priority Critical patent/JP6625992B2/ja
Priority to EP15838333.1A priority patent/EP3189871A4/fr
Publication of WO2016035741A1 publication Critical patent/WO2016035741A1/fr
Priority to US15/433,402 priority patent/US10449338B2/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C63/00—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor
    • B29C63/0065—Heat treatment
    • B29C63/0069—Heat treatment of tubular articles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C63/00—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor
    • B29C63/18—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using tubular layers or sheathings
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C69/00—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore
    • B29C69/001—Combinations of shaping techniques not provided for in a single one of main groups B29C39/00 - B29C67/00, e.g. associations of moulding and joining techniques; Apparatus therefore a shaping technique combined with cutting, e.g. in parts or slices combined with rearranging and joining the cut parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and balloon
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters
    • B29L2031/7543—Balloon catheters

Definitions

  • the present invention relates to a catheter including a balloon reinforced with a reinforcing member and a method for manufacturing the catheter.
  • percutaneous transluminal coronary angioplasty Percutaneous Transluminal Coronary Angioplasty
  • a balloon catheter may be used to improve other blood vessels, bile ducts, trachea, esophagus, urethra, and other lesions formed in the body lumen.
  • the balloon catheter is generally configured to include a long shaft and a balloon that is provided on the distal end side of the shaft and expands in the radial direction, and a stenosis portion in the body is formed by inserting a preceding guide wire. Sent to. Then, in a state where the balloon is arranged in the target stenosis part, the balloon can be expanded by pumping an expansion fluid into the balloon, and the stenosis part can be expanded.
  • the balloon used for the balloon catheter is required to have a desired balloon shape at the time of maximum expansion and to have sufficient strength to expand the lesion in order to effectively treat the lesion. Therefore, conventionally, in order to give the balloon high pressure resistance, low compliance, and the like, a configuration in which a mesh-like reinforcing member is provided in the wall constituting the balloon has been proposed (for example, Japanese Translation of PCT International Publication No. 2008-501408). Issue no.).
  • the balloon catheter conveys the balloon to a lesion in the living body lumen and needs to pass through the living body lumen where the balloon bends. Flexibility that can follow bending is required.
  • the reinforcing member is provided in the wall constituting the balloon, the reinforcing member is integrally fixed to the balloon, and there is no freedom of movement with respect to the wall of the balloon, so that the balloon has sufficient flexibility. There is a problem that it is difficult to do.
  • the present invention has been made in consideration of such problems, and an object of the present invention is to provide a catheter that can improve the flexibility of a balloon reinforced with a reinforcing member, and a method for manufacturing the same.
  • the catheter of the present invention has a cylindrical inner layer and an outer layer having elastic elasticity, and can be expanded and contracted by a change in internal pressure, and the inner layer and the outer layer.
  • reinforcing member at least a part is not directly fixed to the inner layer and the outer layer” means that at least a part of the reinforcing member is not bonded to the inner layer and the outer layer, and the inner layer And since it is not embedded in the outer layer, it means that it can move freely within the space formed between the inner layer and the outer layer.
  • the reinforcing member having the first linear member made of high-strength fiber is disposed between the inner layer and the outer layer of the balloon, the balloon is suitably imparted with high pressure resistance and low compliance.
  • the low compliance property means that when the balloon is expanded at a high pressure, the balloon diameter does not expand indefinitely in response to the pressure, and a high pressure can be expanded with an appropriate diameter.
  • the high strength fiber means a fiber having a tensile strength at break of 2 GPa or more and an elastic modulus of 50 GPa or more.
  • the reinforcing member has a degree of freedom of movement with respect to the balloon, it is possible to maintain good flexibility of the balloon. Thereby, it is possible to realize a balloon having a high passability even in a complicatedly meandering living body lumen.
  • the balloon when the balloon is expanded, expansion of both ends of the reinforcing member in the axial direction is restricted by the expansion restricting portion. Therefore, the balloon is expanded into a desired shape in the living body lumen, and treatment for the lesioned portion is effectively performed. be able to.
  • the reinforcing member may include a second linear member made of a fusible material, and the second linear member may be made of the same material as the expansion restricting portion.
  • the expansion restricting portion is made of a fusible material and is formed by fusing to the first linear member. Therefore, it is possible to easily manufacture a reinforcing member in which expansion at both ends is restricted. .
  • a cylindrical net is formed by the first linear member, and a plurality of the second linear members are arranged at intervals in the circumferential direction of the cylindrical net, and the second linear
  • Each of the members may extend from one end portion to the other end portion of the tubular mesh body along the tubular mesh body, and may be connected to the expansion restriction portion at the both end portions.
  • the cylindrical mesh body that bears the pressure-resistant function is composed of the first linear member made of high-strength fibers
  • the second linear member that bears the fusion function is a configuration independent of the tubular mesh body. It arrange
  • the part responsible for the pressure-resistant function and the part responsible for the fusion function are constructed as independent structures, the pressure-resistant function and the fusion function can be set individually, and the desired pressure resistance can be obtained. In addition, it is possible to easily construct a reinforcing member whose expansion at both ends is restricted.
  • a tubular net may be formed by the first linear member and the second linear member.
  • the 1st linear member and the 2nd linear member are knitted together as a structural member of a cylindrical net-like body. Therefore, the first linear member and the second linear member are knitted to produce a material sleeve, and the material sleeve is heated and cut to easily manufacture a reinforcing member in which expansion restriction portions are formed at both ends. be able to.
  • a total cross-sectional area of the first linear member in a cross section perpendicular to the axial direction may be larger than a total cross-sectional area of the second linear member.
  • the present invention also includes a cylindrical inner layer and an outer layer having elastic elasticity, a balloon that can be expanded and contracted by a change in internal pressure, and a cylindrical net disposed between the inner layer and the outer layer.
  • a material manufacturing method for manufacturing a catheter including a reinforcing member, and including a first linear member made of a high-strength fiber and a second linear member made of a fusible material.
  • a ring-shaped expansion restricting portion made of the fusible material and fused to the first linear member by heating and cutting a plurality of portions in the axial direction of the raw material sleeve and the axial direction of the raw material sleeve is axially And a heating and cutting step for producing the reinforcing member formed at both ends.
  • the meltable material melts at the heating portion and melts with the first linear member.
  • a worn ring-shaped expansion restricting portion is formed.
  • the reinforcing member is composed only of the first linear member (high-strength fiber), generally, the high-strength fiber does not melt and has little fusibility (very low). The fibers are not easily fused together, and both ends are not regulated. Therefore, according to the catheter manufacturing method of the present invention, it is possible to easily manufacture a reinforcing member whose expansion at both ends is restricted.
  • a plurality of the second linear members are arranged at intervals in the circumferential direction of the cylindrical mesh body along the cylindrical mesh body formed by the first linear members.
  • the constructed state may be constructed.
  • the tubular net-like body in the raw material sleeve manufacturing step, may be covered on the outside of the plurality of second linear members arranged along the outer surface of the core rod.
  • the tubular mesh material sleeve may be formed by the first linear member and the second linear member.
  • the first linear member and the second linear member are knitted to produce a material sleeve, and the material sleeve is heated and cut to easily manufacture a reinforcing member in which expansion restriction portions are formed at both ends. can do.
  • a total cross-sectional area of the first linear member in a cross section perpendicular to the axial direction of the raw material sleeve is larger than a total cross-sectional area of the second linear member.
  • the material sleeve may be formed. Thereby, the pressure
  • the flexibility of the balloon reinforced with the reinforcing member can be improved.
  • FIG. 1 is a partially omitted schematic diagram illustrating a configuration of a catheter according to an embodiment of the present invention.
  • FIG. 2 is a schematic cross-sectional view of the distal end portion of the catheter shown in FIG. 1.
  • FIG. 3A is a side view showing the reinforcing member during expansion
  • FIG. 3B is a side view showing the reinforcing member during contraction.
  • 4A is an explanatory diagram of a process for producing a material sleeve
  • FIG. 4B is a cross-sectional view taken along line IVB-IVB in FIG. 4A
  • FIG. 4C is a cross-sectional view of a fusion part
  • FIG. These are explanatory drawing of the process of producing a some reinforcement member from a raw material sleeve.
  • FIG. 5A is an explanatory diagram of a process of covering the inner layer tube with the reinforcing member
  • FIG. 5B is an explanatory diagram of a process of covering the inner layer tube and the reinforcing member with the outer layer tube
  • FIG. 6A is a first explanatory diagram of a step of joining the inner layer tube and the outer layer tube
  • FIG. 6B is a second explanatory diagram of a step of joining the inner layer tube and the outer layer tube
  • FIG. 7A is a first explanatory diagram of a process of joining the distal end of the shaft and the proximal end of the balloon
  • FIG. 7B is a second explanatory diagram of a process of joining the distal end of the shaft and the proximal end of the balloon.
  • FIG. 8A is a first explanatory diagram of a process of joining the inner tube and the tip of the balloon
  • FIG. 8B is a second explanatory diagram of a process of joining the inner tube and the tip of the balloon
  • FIG. 9A is a first explanatory diagram of a process of joining the tip and the inner tube
  • FIG. 9B is a second explanatory diagram of a process of joining the tip and the inner tube. It is a graph which shows the relationship between a pressure and a balloon diameter about the balloon from which the aspect of fixation of a reinforcement member differs, and the balloon in which the reinforcement member is not provided. It is a side view at the time of expansion of the reinforcing member concerning a modification.
  • FIG. 1 is a partially omitted schematic diagram showing the configuration of a catheter 10 according to an embodiment of the present invention.
  • the catheter 10 has a long shaft 12 inserted through a living organ, for example, a coronary artery, and a balloon 14 provided on the distal end side thereof is expanded at the stenosis (lesion), thereby expanding and treating the stenosis.
  • a PTCA Percutaneous Transluminal Coronary Angioplasty
  • the present invention can be applied to catheters other than PTCA dilatation catheters, for example, catheters for improving lesions formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, and other organs. is there.
  • the catheter 10 is arranged in a thin and long shaft 12, a balloon 14 joined to the tip of the shaft 12, and a membrane (wall) constituting the balloon 14.
  • the reinforcing member 28, the inner tube 16 inserted through the shaft 12 and the balloon 14, a tip 18 joined to the tip of the balloon 14, and a hub 20 provided on the base end side of the shaft 12 are provided.
  • the catheter 10 is configured as a so-called “rapid exchange type” catheter in which an opening 22 through which the guide wire 21 is led out is provided in the middle portion of the shaft 12 in the longitudinal direction.
  • the catheter 10 may be configured as an “over-the-wire” type catheter in which a guidewire lumen is formed over the entire length of the catheter 10 and the guidewire 21 is routed from the proximal end of the hub 20. .
  • the shaft 12 is a long and thin flexible tube having both ends opened in the axial direction.
  • the shaft 12 extends from the rear end of the balloon 14 to the tip of the hub 20, and a portion from the tip to the opening 22 forms a double tube that forms an expansion lumen 12 a between the inner tube 16 and the opening.
  • a portion from the portion 22 to the hub 20 is a single tube.
  • the shaft 12 forms an expansion lumen 12 a for supplying the expansion fluid for the balloon 14.
  • the shaft 12 is capable of feeding an expansion fluid pumped from a pressure application device such as an indeflator (not shown) connected via a luer taper 20a provided on the hub 20 to the balloon 14.
  • a pressure application device such as an indeflator (not shown) connected via a luer taper 20a provided on the hub 20 to the balloon 14.
  • the expansion fluid is a contrast medium, physiological saline, or a mixture thereof.
  • the inner tube 16 is a guide wire tube that forms a wire lumen 16a through which the guide wire 21 is inserted.
  • the distal end of the inner tube 16 is located on the distal end side with respect to the proximal end of the distal tip 18.
  • the inner tube 16 extends through the balloon 14 and the shaft 12, and a base end thereof is liquid-tightly joined to an opening 22 (see FIG. 1) formed in an intermediate portion of the shaft 12. Therefore, the guide wire 21 inserted with the distal end opening 18a of the distal tip 18 as an inlet is inserted through the wire lumen 16a of the inner tube 16 from the distal end side to the proximal end side, and is led out from the opening 22 which is an outlet.
  • the inner tube 16 in the balloon 14 is preferably provided with a contrast marker 41.
  • the contrast marker 41 is made of an X-ray (radiation) opaque material (for example, gold, platinum, tungsten, or a mixture thereof), so that the position of the balloon 14 can be viewed in vivo under X-ray contrast. belongs to.
  • the contrast marker 41 may be configured in a cylindrical shape (ring shape), for example. 2, a plurality of contrast markers 41 may be provided in the balloon 14 at intervals in the axial direction of the inner tube 16, or one contrast marker 41 may be provided in the inner tube 16 in the balloon 14. May be provided only.
  • the shaft 12 and the inner tube 16 can be appropriately inserted because the operator can smoothly insert the long catheter 10 into a living organ such as a blood vessel while grasping and operating the proximal end side of the catheter 10.
  • a structure having flexibility and moderate rigidity is preferable. Therefore, the shaft 12 and the inner tube 16 are made of, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), poly It may be formed of a polymer material such as vinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene
  • the balloon 14 can be contracted and expanded by changing the internal pressure.
  • the distal end portion of the balloon 14 is joined to the vicinity of the distal end portion of the inner tube 16, and the proximal end portion of the balloon 14 is joined to the distal end portion of the shaft 12.
  • the internal space of the balloon 14 communicates with the expansion lumen 12a.
  • the inflow (introduction) of the expansion fluid into the balloon 14 and the discharge of the expansion fluid from the balloon 14 can be performed via the expansion lumen 12a.
  • the balloon 14 expands.
  • the balloon 14 has a shape in which a portion between the distal end and the proximal end is expanded with a substantially constant outer diameter along the axial direction, as indicated by a virtual line in FIG.
  • the balloon 14 needs to be moderately flexible so that it can pass through a meandering or bent portion of the body lumen.
  • the balloon 14 needs to have a strength that can surely spread the lesion, and needs to have high pressure resistance and low compliance. Therefore, in the present embodiment, the balloon 14 has a cylindrical inner layer 24 and an outer layer 26 that constitute a fluid-impermeable balloon wall having elastic elasticity, and the inner layer 24 and the outer layer 26 are interposed between the inner layer 24 and the outer layer 26.
  • the reinforcing member 28 is arranged.
  • the balloon 14 and the reinforcing member 28 constitute an expansion portion 15 that can be expanded and contracted in the radial direction at the distal end portion of the catheter 10.
  • the inner layer 24 transmits force to the reinforcing member 28 with the introduction (pressurization) of the expansion fluid into the balloon 14 and swells to a shape regulated by the expanded shape of the reinforcing member 28.
  • the outer layer 26 swells along the expanded shape of the reinforcing member 28 with the introduction (pressurization) of the expansion fluid into the balloon 14, and the reinforcement member with the discharge (decompression) of the expansion fluid from the balloon 14. In order to return 28 to the original shape (position) before expansion, it shrinks to the initial shape. Therefore, the outer layer 26 is preferably made of a material having a high elongation recovery rate.
  • the inner layer 24 and the outer layer 26 are joined to each other at their distal ends and proximal ends by, for example, fusion, adhesion, etc., and the inner layer 24 and the outer layer 26 are sealed to accommodate the reinforcing member 28.
  • An annular storage chamber 17 is formed.
  • Constituent materials of the inner layer 24 and the outer layer 26 include, for example, various rubber materials such as natural rubber, butyl rubber, isoprene rubber, butadiene rubber, styrene-butadiene rubber, silicone rubber, polyurethane, polyester, polyamide, and olefin. , Various thermoplastic elastomers such as styrene, or a mixture thereof.
  • the constituent material of the inner layer 24 and the constituent material of the outer layer 26 may be the same or different.
  • the reinforcing member 28 is a tubular net-like member in which at least a part is movably disposed between the inner layer 24 and the outer layer 26 with respect to the balloon 14 and has a function of increasing the pressure resistance of the balloon 14.
  • the reinforcing member 28 has both end portions (first end portion 31 and second end portion 32) in the axial direction and an intermediate portion 34 that constitutes between the first end portion 31 and the second end portion 32.
  • at least one of the first end portion 31 and the second end portion 32 and the intermediate portion 34 are not directly fixed to the inner layer 24 and the outer layer 26, so that the axial direction relative to the inner layer 24 and the outer layer 26 is achieved. Further, movement in the circumferential direction is allowed.
  • the inner layer 24 and the outer layer 26 may be fixed (for example, fusion, adhesion, etc.) via a gap (mesh) between the first yarns 29 forming the reinforcing member 28.
  • the movement range of the reinforcing member 28 can be regulated while allowing a certain amount of movement of the reinforcing member 28 relative to the inner layer 24 and the outer layer 26.
  • the other of the first end portion 31 and the second end portion 32 is not directly fixed to the inner layer 24 and the outer layer 26, so that the axial movement with respect to the inner layer 24 and the outer layer 26 is prevented.
  • the reinforcing member 28 is not fixed anywhere on the inner layer 24 and the outer layer 26, and accordingly, in the circumferential direction within the range regulated by the inner layer 24 and the outer layer 26 (within the range of the containing chamber 17). And can move freely in the axial direction.
  • first end portion 31 and the second end portion 32 may be fixed to the inner layer 24 or the outer layer 26.
  • the means for fixing is not limited to a specific one, and may be an appropriate fixing means such as fusion or adhesion.
  • the reinforcing member 28 includes a first thread 29 (first linear member) made of high-strength fibers and a second thread 30 (second linear member) made of a fusible material. Further, ring-shaped expansion restricting portions 36 made of a fusible material and fused to the first thread 29 are provided at both ends in the axial direction of the reinforcing member 28. Expansion of the circumferential direction of both ends (the first end 31 and the second end 32) is restricted by the extension restricting portion 36.
  • the cylindrical net-like body 37 is formed by one or more first yarns 29.
  • the cylindrical net 37 is formed into a cylindrical net by weaving (weaving) one or more first yarns 29, and has elasticity in at least the circumferential direction (and radial direction).
  • the method of forming the tubular mesh body 37 is not limited to a specific form, and examples thereof include tubular knitting and braid knitting.
  • the tubular net-like body 37 has first yarns 29 extending in a wave shape in the circumferential direction aligned in the axial direction, and the first yarns 29 having a wave shape adjacent in the axial direction are entangled with each other. (See FIG. 3A).
  • the cylindrical mesh body 37 includes one or more first yarns 29 extending in the first spiral direction and one or more first yarns 29 extending in the second spiral direction. And woven into a cylindrical shape.
  • High strength fiber means a fiber having a tensile strength at break of 2 GPa or more and an elastic modulus of 50 GPa or more, and is also called a super fiber.
  • the first yarn 29 is preferably a twisted yarn made of high-strength fibers.
  • the high-strength fiber include aramid fiber, carbon fiber, polyarylate fiber, PBO fiber, ultrahigh molecular weight polyethylene, and LCP fiber. In general, since these high-strength fibers do not melt even when heated, they have no or very low fusibility with other members.
  • the diameter of the first thread 29 may be about 5 to 100 ⁇ m, for example.
  • the single fiber diameter of the high-strength fiber may be, for example, about 5 to 30 ⁇ m.
  • the high-strength fiber for example, a fiber having a single fiber diameter of 12 ⁇ m can be used, but a thinner fiber or a thicker fiber may be used. In the case of thicker fibers, the twist should be sweet so that the twisted yarn is unwound when no tension is applied.
  • a plurality of second threads 30 made of a fusible material are arranged at intervals in the circumferential direction of the tubular net 37.
  • the fusible material refers to a material that can be softened and melted by heating to a predetermined temperature or higher, and has fusibility to other members.
  • Each of the second yarns 30 extends from one end portion to the other end portion of the tubular mesh body 37 along the tubular mesh body 37 and is connected to the expansion restricting portion 36 at both ends. Further, in the region between the expansion restricting portions 36, the second thread 30 is not bonded or fused to the cylindrical mesh body 37 (first thread 29), and therefore is not fixed.
  • the expansion restricting portion 36 is a portion formed by melting the plurality of second yarns 30 arranged in the circumferential direction in the manufacturing process of the reinforcing member 28, causing the molten material to flow in the circumferential direction, and then solidifying. It is.
  • the molten material is connected in a ring shape with the melting and flow when the second yarn 30 is heated, and expansion of both ends of the reinforcing member 28 can be reliably restricted.
  • the number of second yarns 30, the arrangement interval in the circumferential direction, and / or the thickness are set so as to have a certain degree of strength (rigidity).
  • Examples of the constituent material (meltable material) of the second yarn 30 include polyvinyl chloride, polyethylene, polypropylene, cyclic polyolefin, polystyrene, poly- (4-methylpentene-1), polycarbonate, acrylic resin, and acrylonitrile.
  • Examples include butadiene-styrene copolymers, polyesters such as polyethylene terephthalate and polyethylene naphthalate, butadiene-styrene copolymers, polyamides (for example, nylon 6, nylon 6,6, nylon 6,10, nylon 12), polyamide elastomers, and the like. It is done.
  • the second yarn 30 is disposed on the inner surface side of the tubular mesh body 37.
  • the second thread 30 may be disposed on the outer surface side of the tubular mesh body 37.
  • each of the second yarns 30 may be arranged so as to extend along the axial direction of the reinforcing member 28 at the time of contraction.
  • yarn 30 may be arrange
  • the tip of the inner layer 24 is joined to the inner tube 16. Further, the proximal end portion of the inner layer 24 is joined to the distal end portion (small diameter portion 40) of the shaft 12, and the most distal end portion of the shaft 12 is distal to the innermost end surface of the inner layer 24 inside the inner layer 24. Located on the side. Therefore, the region of the inner layer 24 that can be expanded and contracted when the balloon 14 is expanded or contracted (hereinafter referred to as “the expandable / contractable region 25 of the inner layer 24”) is the junction between the inner layer 24 and the inner tube 16 and the most distal portion of the shaft 12. The part between.
  • the most proximal end portion of the reinforcing member 28 is located closer to the proximal end side than the most proximal end portion of the stretchable region 25 of the inner layer 24.
  • the second end portion 32 of the reinforcing member 28 is proximal to the most distal end portion of the shaft 12 in the housing chamber 17 formed between the inner layer 24 and the outer layer 26 of the balloon 14. You may arrange in. Thereby, the second end portion 32 of the reinforcing member 28 is less affected by the expansion of the balloon 14 when the balloon 14 is expanded, and contributes to the restriction of the maximum expansion diameter of the balloon 14 by the reinforcing member 28.
  • FIG. 3A is a side view showing the reinforcing member 28 at the time of expansion
  • FIG. 3B is a side view showing the reinforcing member 28 at the time of contraction.
  • the first yarns 29 are in a tensioned state
  • the outer diameter is not more than a certain value.
  • the shape of the reinforcing member 28 (intermediate portion 34) at the time of expansion is the straight portion 42 having a substantially constant outer diameter and the straight portion 42. It has outer diameter changing portions (tapered portions) 45 and 46 which are located on both sides of the portion 42 and reduce in diameter toward the outside in the axial direction.
  • the expanded balloon 14 has a straight portion having a substantially constant outer shape and both sides of the straight portion. And an outer diameter changing portion (tapered portion) that is located at the outer diameter and contracts toward the outside in the axial direction.
  • the contrast marker 41 is disposed on the inner tube 16 so that the position of the straight portion of the balloon 14 can be seen.
  • the reinforcing member 28 having the tubular mesh body 37 formed by a knitting method in which the wave-shaped first yarns 29 adjacent in the axial direction are entangled with each other, as shown in FIG.
  • the reinforcing member 28 tubular mesh body 37
  • the first yarns 29 of the mesh are displaced, and the first yarns 29 adjacent in the axial direction can be overlapped with each other, and are adjacent in the axial direction. It is possible to bend by rotating the entangled portion of the first yarns 29. Accordingly, such a reinforcing member 28 is excellent in bending flexibility.
  • the distal tip 18 provided on the distal end side of the balloon 14 flexibly advances a curved portion or a concavo-convex portion in a living organ as the forefront of the catheter 10, and also a lesioned portion (stenosis portion).
  • This is a portion that penetrates and guides the smooth insertion of the catheter 10, and is a short tube whose inner diameter is substantially the same as the inner diameter of the inner tube 16.
  • the distal tip 18 is externally fitted and liquid-tightly joined to the distal end portion of the inner tube 16 and protrudes more distally than the distal opening 18 a of the wire lumen 16 a, and its proximal end surface is joined to the distal end surface of the balloon 14.
  • the distal end opening 18 a of the distal end tip 18 communicates with the wire lumen 16 a of the inner tube 16 and serves as an inlet of the guide wire 21.
  • the tip 18 is configured more flexibly than at least the shaft 12 and the inner tube 16 by appropriately setting the material and shape thereof.
  • the tip tip 18 may be omitted.
  • the tip end position of the inner tube 16 and the tip end position of the balloon 14 are matched with each other, or the inner tube 16 is more than the tip end position of the balloon 14. It is good to have a configuration in which the most advanced position of is slightly protruded.
  • FIG. 4A to 4D are explanatory views of the manufacturing process of the reinforcing member 28.
  • FIG. 4A first, a step of producing a cylindrical mesh material sleeve 50 that is a material of the reinforcing member 28 (material sleeve production step) is performed.
  • the material sleeve 50 has a length equal to or longer than a plurality of reinforcing members 28.
  • a plurality of second threads 30 are arranged at intervals in the circumferential direction of the tubular mesh body 37 along the tubular mesh body 37 formed by the first threads 29.
  • a state is constructed (see also FIG. 4B, which is a cross-sectional view along the line IVB-IVB in FIG. 4A).
  • a plurality of second yarns 30 are arranged along the outer surface of the core bar 39 at intervals in the circumferential direction, and further, outside the plurality of second yarns 30 arranged. It is preferable to cover the tubular net 37.
  • the plurality of second yarns 30 are held between the cylindrical mesh body 37 and the core rod 39, the second yarns are not required without a separate mechanism for holding the second yarns 30. 30 can be properly placed and is efficient.
  • a ring-shaped expansion restricting portion 36 made of a fusible material and fused to the first thread 29 is formed.
  • a step (heating and cutting step) of producing one or more (a plurality of reinforcing members in FIG. 4D) reinforcing members 28 formed at both ends in the axial direction is performed.
  • a step of covering the reinforcing member 28 on the inner layer tube 52 that is the material of the inner layer 24 is performed.
  • both end portions of the inner layer tube 52 are protruded from both end openings of the reinforcing member 28.
  • the outer layer tube 54 is covered so that the entire length of the reinforcing member 28 is accommodated in the outer layer tube 54 (both ends of the outer layer 26 protrude in the axial direction from both ends of the reinforcing member 28).
  • a step of joining the inner layer tube 52 and the outer layer tube 54 is performed. Specifically, first, as shown in FIG. 6A, the core rod 56 (core metal) is inserted inside the inner layer tube 52 (an assembly of the inner layer tube 52, the outer layer tube 54 and the reinforcing member 28). Next, as shown in FIG. 6B, one end portions and the other end portions of the inner layer tube 52 and the outer layer tube 54 are joined by fusion. As a result, an annular storage chamber 17 that is sealed between the inner layer 24 and the outer layer 26 is formed, and the expanded portion 15 in which the reinforcing member 28 is disposed in the storage chamber 17 is obtained. After the inner / outer layer joining step, the core rod 56 is removed.
  • the reinforcing member 28 is only disposed in the storage chamber 17 and is not joined to other members by fusion, adhesion, or the like. It is not fixed to any part of the inner layer 24 and the outer layer 26).
  • a step of joining the balloon 14 (expanded portion 15) and the shaft 12 is performed (FIGS. 7A and 7B).
  • the small diameter portion 40 is formed at the tip portion of the shaft 12.
  • the small diameter portion 40 of the shaft 12 is inserted into the proximal end side of the balloon 14.
  • FIG. 7B the proximal end portion of the balloon 14 and the distal end portion (the small diameter portion 40) of the shaft 12 are joined by fusion bonding.
  • the contrast marker 41 is attached to the inner tube 16. Specifically, a cylindrical contrast marker 41 having an inner diameter slightly larger than that of the inner tube 16 is passed outside the inner tube 16 and a cored bar is inserted into the inner tube 16, and then the entire circumference of the contrast marker 41 is beaten (swaging process). ), The contrast marker 41 is fixed to the inner tube 16 by reducing the diameter of the contrast marker 41 and biting it into the inner tube 16.
  • a step of bonding the balloon 14 and the inner tube 16 (balloon / inner tube bonding step) is performed (FIGS. 8A and 8B). Specifically, as shown in FIG. 8A, the inner tube 16 is inserted into the balloon 14 and the shaft 12. Next, as shown in FIG. 8B, the tip of the balloon 14 and the inner tube 16 are joined by fusion.
  • a step of joining the tip 18 and the inner tube 16 is performed (FIGS. 9A and 9B). Specifically, first, the tip of the inner tube 16 is cut to adjust the length (FIG. 9A). Next, the proximal end portion of the distal tip 18 is externally fitted to the distal end portion of the inner tube 16, and the proximal end portion of the distal tip 18 and the distal end portion of the inner tube 16 are joined by fusion (FIG. 9B).
  • the step of joining the base end of the shaft 12 and the tip of the hub 20 can be performed at an arbitrary timing.
  • the shaft / hub joining process may be performed before the balloon / shaft joining process, after the tip / inner pipe joining process, or between the balloon / shaft joining process and the tip / inner pipe joining process. It may be between.
  • fusion is exemplified as means for joining the members, but other joining means such as adhesion may be applied instead of fusion.
  • the catheter 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.
  • the treatment using the catheter 10 is performed as follows, for example.
  • the form of a lesion (stenosis) occurring in a blood vessel is identified by an intravascular imaging method or an intravascular ultrasound diagnostic method.
  • the guide wire 21 is introduced into the blood vessel percutaneously by, for example, the Seldinger method, and the guide wire 21 is inserted from the distal end opening 18a of the distal tip 18 into the wire lumen 16a of the inner tube 16.
  • the catheter 10 is inserted into the blood vessel while being led out to the opening 22.
  • the guide wire 21 is advanced to the target lesion, passed through the lesion, and placed, and the catheter 10 is advanced along the guide wire 21.
  • the balloon 14 When the distal tip 18 of the catheter 10 passes through the lesioned part, the balloon 14 is positioned at the lesioned part. Then, the expansion fluid (for example, contrast medium) is pumped from the hub 20 side into the expansion lumen 12a, so that the balloon 14 is expanded to expand the lesion, thereby treating the lesion. Can do. Next, the expansion fluid is sucked from the inside of the balloon 14 through the expansion lumen 12a toward the hub 20, and the balloon 14 is deflated again. If there is another lesion in the living body lumen that requires treatment, the balloon 14 is delivered to the other lesion, and the balloon 14 is expanded and contracted in the same manner as described above. When the treatment for all lesions to be treated is completed, the catheter 10 is removed from the body.
  • the expansion fluid for example, contrast medium
  • the reinforcing member 28 having the first thread 29 made of high-strength fiber is disposed between the inner layer 24 and the outer layer 26 of the balloon 14, High pressure resistance and low compliance can be suitably imparted to the balloon 14. Further, since the reinforcing member 28 has a degree of freedom of movement with respect to the balloon 14, good flexibility of the balloon 14 can be maintained. Thereby, it is possible to realize the balloon 14 having a high passability even in a complicatedly meandering living body lumen.
  • At least one of the first end portion 31 and the second end portion 32 of the reinforcing member 28 and the intermediate portion 34 are not directly fixed to the balloon 14. That is, almost the entire reinforcing member 28 has a degree of freedom of movement in the axial direction and the circumferential direction with respect to the balloon 14, so that the good flexibility of the balloon 14 can be maintained. Thereby, the balloon 14 which has the high permeability
  • FIG. 10 is a graph showing the relationship between the pressure and the balloon diameter for the balloons A1 to A3 that are provided with the reinforcing member 28 but are differently fixed and the balloon B that is not provided with the reinforcing member 28.
  • both ends of the reinforcing member 28 in the axial direction of the balloon A ⁇ b> 1 are fixed to the inner layer 24.
  • the reinforcing member 28 is not fixed anywhere.
  • the balloons A1 to A3 provided with the reinforcing member 28 have a gradual increase in the diameter of the balloon with respect to the increase in pressure and higher pressure resistance than the balloon B without the reinforcing member 28. It can be seen that the compliance is low. On the other hand, in the balloons A1 to A3 provided with the reinforcing member 28, no significant difference is observed depending on the manner in which the reinforcing member 28 is fixed. Therefore, it can be understood that a balloon with high pressure resistance and low compliance can be realized by providing the reinforcing member 28 between the inner layer 24 and the outer layer 26 regardless of whether the reinforcing member 28 is fixed or not.
  • At least one of the both end portions of the reinforcing member 28 and the intermediate portion 34 are formed of the balloon. It is better not to fix to the 14 inner layers 24 and the outer layer 26.
  • the balloon 14 when the balloon 14 is expanded, expansion of both ends in the axial direction of the reinforcing member 28 is restricted by the expansion restricting portion 36. Therefore, the balloon 14 is expanded into a desired shape in the living body lumen. Thus, it is possible to effectively treat the lesioned part. Moreover, since the expansion restricting portion 36 is made of a fusible material and is formed by being fused to the first yarn 29, the reinforcing member 28 in which expansion at both ends is restricted can be easily manufactured. .
  • the cylindrical mesh body 37 that bears the pressure resistance function is configured by the first yarn 29 made of high-strength fibers, and the second structure that bears the fusion function as a configuration independent of the cylindrical mesh body 37.
  • the thread 30 is arranged along the tubular mesh body 37. Therefore, since the part responsible for the pressure-resistant function and the part responsible for the fusion function are constructed as independent structures, the pressure-resistant function and the fusion function can be set individually, and the desired pressure resistance can be obtained. In addition, it is possible to easily construct the reinforcing member 28 whose expansion at both ends is restricted.
  • the balloon 14 expands and contracts with elastic expansion and contraction, and is a zero-folding type that does not fold in the contracted state. Easy to return to. Therefore, when a plurality of lesions occurring at different locations in the living body lumen are treated with the same balloon 14, the outer diameter after re-contraction is suppressed from becoming larger than the initial outer diameter. Even after re-contraction, good passage through the body lumen can be maintained.
  • the catheter 10 can be easily produced.
  • a balloon made of a non-stretchable material it is necessary to form the balloon material after forming the balloon material, thereby forming the desired balloon shape. It is necessary to perform a wrapping process (folding one or more outer peripheral portions of the balloon in the circumferential direction).
  • blow molding is not required and the subsequent lapping process is not required. Can be reduced.
  • expansion of the first end portion 31 and the second end portion 32 of the reinforcing member 28 is restricted by the expansion restricting portion 36 in the circumferential direction and the radial direction (see FIG. 2).
  • the maximum expansion diameter of the intermediate portion 34 located between the first end portion 31 and the second end portion 32 can be effectively restricted, and the function as the reinforcing member 28 can be achieved. It can exhibit suitably.
  • the reinforcing member 28 is formed by knitting one or more first yarns 29 into a cylindrical shape, and the wave-shaped first yarns 29 adjacent in the axial direction are entangled with each other (FIG. 3A). reference). With this configuration, when the reinforcing member 28 is compressed in the circumferential direction, the first thread 29 is folded in the circumferential direction, and when compressed in the axial direction, the first thread 29 of the mesh is displaced in the axial direction. For this reason, the reinforcing member 28 can bend flexibly.
  • the intertwined portion of the first threads 29 constitutes a connecting portion.
  • the connecting portion is formed such that the first yarns 29 are not bonded to each other and the first yarns 29 are movable.
  • the catheter manufacturing method according to the present embodiment when the reinforcing member 28 having a desired length is cut out from the material sleeve 50 by heating and cutting the material sleeve 50, the fusible material is melted at the heating portion. A ring-shaped expansion restricting portion 36 fused to the first thread 29 is formed.
  • the high-strength fiber in the case of a reinforcing member (not shown) composed only of the first yarn 29 (high-strength fiber), the high-strength fiber generally does not melt and has little fusibility (very low). The fibers are not easily fused at both ends of the member, and both ends are not regulated. Therefore, according to the catheter manufacturing method according to the present embodiment, it is possible to easily manufacture the reinforcing member 28 in which expansion of both ends is restricted.
  • the cylindrical mesh body 37 in the raw material sleeve manufacturing process, when the cylindrical mesh body 37 is put on the outside of the plurality of second threads 30 arranged along the outer surface of the core bar 39, the cylindrical mesh body 37 and the core A plurality of second linear members are held between the bars 39. Therefore, the reinforcing member 28 can be produced efficiently.
  • a cylindrical net 37a is formed by one or more first yarns 29 made of high-strength fibers and one or more second yarns 30 made of a fusible material.
  • the method of forming the tubular mesh body 37a is not particularly limited, and may be the above-described tubular knitting, braid knitting, or the like.
  • the first yarn 29 and the second yarn 30 are knitted together as the constituent members of the tubular mesh body 37a. Therefore, in the raw material sleeve manufacturing process related to the manufacture of the reinforcing member 28a, the first sleeve 29 and the second yarn 30 are knitted to prepare the raw material sleeve, and one or more portions in the axial direction of the raw material sleeve are heated and cut. By doing so, the reinforcing member 28a in which the expansion restricting portions 36 are formed at both ends can be easily manufactured.
  • the pressure resistance required for the reinforcing member 28a is suitably secured. can do.
  • the total cross-sectional area of the first yarn 29 in the cross section perpendicular to the axial direction of the material sleeve is larger than the total cross-sectional area of the second yarn 30.
  • a material sleeve is formed.
  • the number of the first yarns 29 constituting the material sleeve is made larger than the number of the second yarns 30 or the thickness of the first yarns 29 constituting the material sleeve is set to the second yarn 30.
  • the total cross-sectional area of the first yarn 29 may be made larger than the total cross-sectional area of the second yarn 30 by making it thicker than the thickness of the first yarn 29.
  • the total cross-sectional area of the first yarn 29 may be made larger than the total cross-sectional area of the second yarn 30 by adjusting the number and thickness of the first yarn 29 and the second yarn 30. .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Manufacturing & Machinery (AREA)
  • Anesthesiology (AREA)
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Abstract

　Dans un cathéter (10), un élément (28) de renforcement sous forme d'un filet cylindrique est placé entre une couche interne (24) et une couche externe (26) constituant un ballonnet. Cet élément (28) de renforcement possède un premier fil (29) constitué de fibres à résistance élevée. Au niveau de chaque extrémité en direction radiale de l'élément (28) de renforcement est située une partie (36) de régulation de dilatation, sous la forme d'un anneau, laquelle est jointe par fusion au fil (29). Grâce à cette partie (36) de régulation de dilatation, la dilatation en direction circonférentielle des deux parties d'extrémité de l'élément (28) de renforcement est régulée.
PCT/JP2015/074625 2014-09-04 2015-08-31 Cathéter et procédé de fabrication de celui-ci WO2016035741A1 (fr)

Priority Applications (3)

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JP2016546632A JP6625992B2 (ja) 2014-09-04 2015-08-31 カテーテル及びその製造方法
EP15838333.1A EP3189871A4 (fr) 2014-09-04 2015-08-31 Cathéter et procédé de fabrication de celui-ci
US15/433,402 US10449338B2 (en) 2014-09-04 2017-02-15 Catheter and method of manufacturing the same

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JP2014-180092 2014-09-04
JP2014180092 2014-09-04

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US15/433,402 Continuation US10449338B2 (en) 2014-09-04 2017-02-15 Catheter and method of manufacturing the same

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EP (1) EP3189871A4 (fr)
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WO2019181837A1 (fr) * 2018-03-19 2019-09-26 日本ゼオン株式会社 Cathéter à ballonnet pour l'élimination de calculs

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WO2016035739A1 (fr) * 2014-09-04 2016-03-10 テルモ株式会社 Cathéter
JP7160633B2 (ja) * 2018-10-30 2022-10-25 クリエートメディック株式会社 カテーテル

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JP5304005B2 (ja) * 2008-04-17 2013-10-02 株式会社カネカ カテーテル用複合バルーン及びその製造方法
WO2012169593A1 (fr) * 2011-06-08 2012-12-13 株式会社カネカ Cathéter à ballonnet et procédé de production de celui-ci

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JP2014518739A (ja) * 2011-06-03 2014-08-07 シー・アール・バード・インコーポレーテッド 放射線不透過性の医療用バルーン
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Publication number Priority date Publication date Assignee Title
WO2019181837A1 (fr) * 2018-03-19 2019-09-26 日本ゼオン株式会社 Cathéter à ballonnet pour l'élimination de calculs
JPWO2019181837A1 (ja) * 2018-03-19 2021-03-11 日本ゼオン株式会社 結石除去用バルーンカテーテル
JP7306376B2 (ja) 2018-03-19 2023-07-11 日本ゼオン株式会社 結石除去用バルーンカテーテル

Also Published As

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US10449338B2 (en) 2019-10-22
EP3189871A1 (fr) 2017-07-12
US20170157373A1 (en) 2017-06-08
JP6625992B2 (ja) 2019-12-25
JPWO2016035741A1 (ja) 2017-06-22
EP3189871A4 (fr) 2018-05-09

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